- Embyronic stem cells do not work in myocardial scar tissue. They form fibroblasts or more scar. They die out.
- Cardiomyocytes die out when injected in myocardial scar tissue (they require too much oxygen and nutrients) and cannot be multiplied to therapeutic dosages. They are electrically unstable in scar tissue.
- Adipose, blood, bone marrow, placenta and embryonic stem cells cannot grow new muscle in scar tissue.
- Cardiac stem cells only work to form new muscle on the rim edge of a scar, not in the center.
- Only myoblasts or immature myoblasts are able to form new contractile muscle in scar tissue.
- Over 4,000 animal studies have been completed, with the nearly universal majority yielding positive results for myoblast transplantation.
- More than 400 patients have been enrolled in clinical trials for myoblast transplantation since June 2000.
- Direct needle catheter injection into scar tissue is far superior to coronary infusion or other methods.
- Targeted cell delivery is not needed. The cells naturally spread all over scar tissue if they are injected anywhere near the scar tissue and migrate to the injured tissue areas.
- In trials, 84% of myoblast-treated heart-failure patients have improved; only 16% worsened.
- 69% of non-treated control or placebo patients in trials have worsened.
- 33% of myoblast-treated patients with only one injection session exhibited substantial improvement in cardiac function.
- Myoblast-treated patients improved 95.7 meters over placebo patients (-4 meters decline) in exercise capacity in controlled clinical trials. No other stem cell type, drug or device has ever beat 53 meters improvement in a controlled trial; cardiac resynchronization therapy (CRT) pacers achieved an improvement of 20 meters, cardiac stem cells increased exercise capacity by 53 meters, while drugs were associated with a 4-meter decline.
- It is expected that repeat myoblast transplantation will reduce by half hospitalizations from heart failure. Heart-failure hospitalizations and associated care are the single leading drain on Medicare in the USA.
- Myoblast-transplanted patients have a lower incidence of serious arrhythmias six months and one year after treatment than non-treated patients. Premature ventricular contraction (PVC) data demonstrates 0.05% for myoblast-treated patients and 3% for non-treated patients.
- 33% of myoblast-treated patients improve two heart failure classes.
- 33% of myoblast-treated patients have greater than 15% improvement in left ventricular ejection fraction (LVEF) via dobutamine stress echo studies.
- Pressure-volume (PV) loop studies have demonstrated myoblast-treated patients have substantial positive reverse re-modeling.
- Close to $300 million has been spent to date on myoblast transplantation for heart failure research. Bioheart and Leonhardt Ventures have supported close to 40% of this total.
- Pre-treating scar with microRNAs, stromal cell-derived factor-1 (SDF-1) and hydrogel before cell transplantation can improve results.
- Genetically modifying cells to over-express SDF-1 can double improvement results and the consistency of results. Myoblasts alone lead to 27% improvement, while SDF-1 myoblasts result in 54% improvement. 66% of test subjects received substantial new muscle formation with SDF-1 myoblasts compared to 33% with ordinary myoblasts.
- New muscle formed with myoblasts is stretch-activated.
- Injecting cardiac stem cells or induced pluripotent stem (iPS) cells at the rim edge of scar and myoblasts in the center of scar in combination may be worth studying.
- Electrical stimulation before, during and after stem-cell transplantation can dramatically improve results.
- Nutrient hydrogel can help improve myoblast cell engraftment in scar tissue.
- Repeat injection sessions can dramatically improve results. It is believed now up to 36 sessions of percutaneous injections of 300 million cells each may be needed for full myocardial scar recovery.
Howard Leonhardt To Present 25 Years Of Experience With Stem Cell Transplantation At 28th Annual Interventional Cardiology Conference In Snowmass, Colo., On March 28
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